This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.

Saturday, August 8, 2009

Now here is a very surprising editorial from the Aug. 7 Australian. It was penned by Lawrence O. Gostin, now a visiting professor at the University of Sydney. Gostin authored the Model State Emergency Health Powers Act, on contract to CDC. Versions (or parts) of the Act have been passed so far in 38 states. The model Act, you may remember, gives enormous powers to governors during medical emergencies, including the right to seize private property:

"During a public health emergency, state and local officials are authorized to use and appropriate property as necessary for the care, treatment and housing of patients, and to destroy contaminated facilities or materials."

Yet a governor can declare an emergency at whim:

"The governor may act to declare a public health emergency without consulting with the public health authority or other experts when the situation calls for prompt and timely action."

But now Gostin is voicing caution, at least about the need to consider the safety of new therapeutic products. Wonder if he has had second thoughts about the danger to our Democracy of his Model Act?

Dose-sparing strategies to avoid depletion of an already short vaccine supply will increase risks. Studies show that vaccines containing adjuvants cause more adverse effects. More worrying, because the clinical trials are so small, is that adverse effects will not be detected until the vaccine has already been used on a large population. It's essential to conduct rigorous post-marketing surveillance to pick up rare, but serious, effects...

The Rudd government needs to assess carefully the risks and benefits of rapid approval and roll-out of a vaccine. Thus far swine flu has been mild, with most patients making a full recovery. The fear, of course, is that H1N1 will mutate, becoming much more lethal. This was what happened with the second wave of the 1918 Spanish flu, which killed more than 50 million people in a much less populated world. It is a remote possibility, but one that demands watchfulness.

The most prudent course today would be to conduct careful clinical trials with due scientific deliberation; use the vaccine on high-risk groups, phasing in the full population only as evidence of safety and effectiveness becomes clearer; and conducting post-market surveillance for adverse effects.

AUSTRALIANS may have to wait months until a swine flu vaccine is available, federal Health Minister Nicola Roxon said.

Ms Roxon said the government was keen to make a vaccine available as soon as it is safe and effective, but a decision has yet to be made.

"We are happy to take advice that we may not need to wait until the end of the clinical trials but I am not going to be in a position that I will override the release and the mass rollout of the vaccine until we have that advice," she said.

But World Health Organisation flu chief Keiji Fukuda warned of the potential dangers of untested vaccines, saying on Friday: 'One of the things which cannot be compromised is the safety of vaccines.

Despite statements by WHO's director of vaccine research, Marie-Paul Kieny, to the contrary, WHo seems to currently be erring on the side of safety. Agence France Presse carried the following news in mid July:

World Health Organisation chief Margaret Chan cast doubt Wednesday on the government's plans to start vaccinating from next month those most at risk of contracting swine flu.

Chan told the Guardian newspaper that a vaccine would not be available for several months, despite statements from health officials here that the first stocks would start arriving in August.

"There's no vaccine. One should be available soon, in August. But having a vaccine available is not the same as having a vaccine that has proven safe," WHO director general Chan said in an interview with the newspaper. "Clinical trial data will not be available for another two to three months," she said.

At least Australia, in the midst of a severe H1N1 epidemic, and WHO, have kept their wits about them with regard to "quick fix" vaccines that may be more dangerous than the disease they are designed to prevent.

After swimming with dolphins at Key Largo, they checked me out at the edge of the pool

Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)

Why am I blogging?

Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.

Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.

The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.

Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.

Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.

Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?

So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.

Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.

Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.

Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.